The following data is part of a premarket notification filed by Allergan, Inc. with the FDA for Amo Diplomax/opsys Console.
| Device ID | K971186 |
| 510k Number | K971186 |
| Device Name: | AMO DIPLOMAX/OPSYS CONSOLE |
| Classification | Unit, Phacofragmentation |
| Applicant | ALLERGAN, INC. 2525 DUPONT DR. Irvine, CA 92612 |
| Contact | Monique M Heyninck-duran |
| Correspondent | Monique M Heyninck-duran ALLERGAN, INC. 2525 DUPONT DR. Irvine, CA 92612 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-01 |
| Decision Date | 1997-06-13 |
| Summary: | summary |